Stages of Drug Development:
1 | IND | Animal tests |
2 | IND Review by FDA and local IRB | Animal tests |
3 | Phase 1 | Healthy volunteers, tests safety |
4 | Phase 2 | Sick volunteers, tests effectiveness |
5 | Phase 3 | Larger scale, test effectiveness and adverse effects |
6 | Post-marketing | Review |
7 | NDA application | |
8 | FDA Review and decision | |
9 | FDA Review and decision | |
10 | FDA decision |